Pelvic Fracture Pubic Rami Multiple - Unstable ClosedNCT04202315
Use of Virtual Reality for Pelvic External Fixator Removal
A study testing Virtual Reality in people with Pelvic Fracture Pubic Rami Multiple - Unstable Closed, run by University of Washington at 1 site in United States.
Trial summary
Assessing the role of virtual reality in decreasing pain and improving patient satisfaction in outpatient removal of pelvic external fixator constructs. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pelvic Fracture Pubic Rami Multiple - Unstable Closed
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pelvis external fixator placed at study institution
- External fixator placed for pelvic instability
Who cannot join
- Infected pin or pins
- Loose pin or pins
- Psych history
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
Hunter Hoffman, PhD
About this study
Assessing the role of virtual reality in decreasing pain and improving patient satisfaction in outpatient removal of pelvic external fixator constructs.
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Utilizing Virtual Reality during external fixator removal in outpatient clinic setting.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care, no Virtual Reality |
| Virtual Reality | Experimental | Standard of care plus Virtual Reality Receives: Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain score during removal of external fixator
Measured: During procedure
Secondary outcomes (1)
Patient Satisfaction
Self reported patient satisfaction, comparing no virtual reality to virtual reality
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start15 Jan 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Fracture Pubic Rami Multiple - Unstable ClosedStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reza Firoozabadi, University of Washington
- Investigators
- Reza Firoozabadi, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202315
- Sponsor's protocol ID
- STUDY00002673
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality for Pelvic External Fixator Removal
- ClinicalTrials.gov ID
- NCT04202315
- Acronym / sponsor ID
- STUDY00002673
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessing the role of virtual reality in decreasing pain and improving patient satisfaction in outpatient removal of pelvic external fixator constructs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care, no Virtual Reality |
| Virtual Reality | Experimental | Other: Virtual RealityStandard of care plus Virtual Reality |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pelvis external fixator placed at study institution
- External fixator placed for pelvic instability
Key exclusion criteria (3 listed)
- Infected pin or pins
- Loose pin or pins
- Psych history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityUtilizing Virtual Reality during external fixator removal in outpatient clinic setting. | Other | Virtual Reality |
Primary outcome
Pain Score
Time frame: During procedure
Pain score during removal of external fixator
1 secondary outcome
Patient Satisfaction
Time frame: immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Firoozabadi, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pelvic Fracture Pubic Rami Multiple - Unstable Closed, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hunter Hoffman, PhD (2067442172, hunthoff@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.